Adjuvant radiotherapy after radical cystectomy for patients with muscle invasive bladder cancer: a phase II trial

Abstract

BackgroundNeo-adjuvant chemotherapy followed by radical cystectomy with extended pelvic lymph node dissection is considered to be the treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors develop a pelvic recurrence. We hypothesize that postoperative adjuvant external beam radiotherapy (EBRT) might prevent local and lymph node recurrence and improve disease free- and overall survival as loco-regional recurrence is linked to the development of distant metastasis.MethodsWe plan to perform a multicentric prospective phase two study including 76 patients. Eligible patients are patients with MIBC, treated with radical cystectomy and presenting with ≥1 of the following characteristics:Pathological (p)T3 stage + presence of lymphovascular invasion on pathological examinationpT4 stage<10 lymph nodes removedpositive lymph nodespositive surgical margins Patients will have a 18F–FDG PET-CT to rule out the presence of distant metastasis prior to EBRT. A median dose of 50 Gy in 25 fractions is prescribed to the pelvic lymph node regions with inclusion of the operative bladder bed in case of a positive surgical margin. Patients with suspected lymph nodes on PET- CT can still be included in the trial, but a simultaneous integrated boost to 74Gy to the positive lymph nodes will be delivered. Blood and urine samples will be collected on day-1 and last day of EBRT for evaluation of biomarkers. The primary endpoint is evaluation of acute ≥Grade 3 intestinal or grade 4 urinary toxicity, in case of a neo-bladder reconstruction, within 12 weeks after EBRT. Secondary endpoints are: assessment of QOL, late RTOG toxicity, local control, disease free survival and overall survival. Biomarkers in urine and blood will be correlated with secondary survival endpoints.DiscussionThis is a prospective phase 2 trial re-assessing the feasibility of adjuvant radiotherapy in high-risk MIBC.Trial registrationThe Ethics committee of the Ghent University Hospital (EC2014/0630) approved this study on 31/07/2014.Trial registration on Clinicaltrials.gov (NCT02397434) on November 19, 2014.

A rare case of for synchronous advanced cancer of ascending colon and urinary bladder with simultaneous laparoscopic resection: A case report

“…In limited cases, there have been reports that good surgical results were obtained in combination with neoadjuvant and/or adjuvant systemic chemotherapy of bladder cancer with metastasis [[12], [13], [14]]. Additionally, the effect of adjuvant radiotherapy for advanced bladder cancer was expected to be beneficial in several reports [[14], [15], [16]]. We regret that we were unable to complete this treatment, which was expected to be efficacious.…”

The View Outside of the Box: Reporting Outcomes Following Radical Cystectomy Using Pentafecta From a Multicenter Retrospective Analysis

“…Then, Oh et al that studied the Korean Robot-Assisted Radical Cystectomy Study Group observed significantly greater OS and CSS in the group that achieved pentafecta and reported a 48% decrease in the overall mortality in those patients (23). As a consequence, the quality of RC defined by pentafecta achievement may serve as an additional clinical prognosticator, when stepwise management of the disease is planned to increase poor results of the unimodal approach (39,40).…”

Adjuvant Radiotherapy After Radical Cystectomy for Patients with High-risk Muscle-invasive Bladder Cancer: Results of a Multicentric Phase II Trial

“…The study started in August 2014, and the last patient was included in October 2020. The study design, treatment details, sample size calculation, and endpoints have previously been reported in detail [15].…”